Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, we're joined by Steve Gens, founder of Gens and Associates, to talk about where AI is really heading in regulatory, beyond the hype cycle.

Steve’s top resources:

 * Do you have a business case for AI? Answer a few questions to find out [https://en.ennov.com/platform/artificial-intelligence/#assess]
 * Know what to ask vendors: Download the AI Vendor Checklist [https://en.ennov.com/insider/guide-ai-vendor-checklist/]
 * Simplify agency correspondence with AI: Watch AI in action [https://en.ennov.com/insider/managing-agency-correspondence-with-ai/]

AI in Regulatory: Agents, Answers, Action!

Preeya Beczek, a regulatory affairs and compliance expert, joins us to discuss the practical challenges of change management and explore what it takes to implement it effectively.

Preeya’s Top Resources:

 * Rethink change control across connected systems: Read the connected change control blog [https://en.ennov.com/blog/quality-blog/change-control-regulatory-affairs-connected-systems/]
 * See real impact on regulatory productivity: Explore the Septodont case study [https://en.ennov.com/insider/regulatory/case-study-septodont/]
 * Break down silos across teams and systems: Learn how to align quality and regulatory [https://en.ennov.com/insider/regulatory/white-paper-unified-quality-rim/]

The Challenge of Change Management

Diarmuid Waide, Regulatory Product Specialist here at Ennov, gives us a behind-the-scenes look at the EMA’s eCTD 4.0 pilot and what it revealed about the gap between theory and real-world readiness.

Our Top Resources

 * Track key implementation deadlines: Explore the updated eCTD 4.0 timeline [https://en.ennov.com/blog/regulatory-blog/ectd-4-0-timeline/]
 * Know what’s changing and why it matters: Read the readiness guide [https://en.ennov.com/blog/regulatory-blog/ectd-4-0-whats-changing-and-how-to-be-ready/%C2%A0]
 * Get everything in one place: Visit the eCTD 4.0 resource hub [https://en.ennov.com/ectd-content-hub/]

eCTD 4.0 Pilots: Cleared for Takeoff!

In this special edition, I bring you highlights from our 2025 Ennov Europe User Meeting in Paris, where I spoke with four regulatory leaders from across the industry. I asked each of them the same three questions about their biggest priorities, challenges, and innovation, so you can compare perspectives, borrow what works, and plan ahead for 2026.

Our Top Resources

 * Get ready for eCTD 4.0: View the upcoming deadlines [https://en.ennov.com/blog/regulatory-blog/ectd-4-0-timeline/]
 * See how AI is being used today: Read the top use cases [https://en.ennov.com/platform/artificial-intelligence/]
 * Set your strategy for 2026: Download the IDMP Starter Pack [https://en.ennov.com/insider/regulatory/idmp-starter-pack/]

Perspectives from Paris: What’s on the Horizon for 2026

Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, we're joined by Michiel Stam, management consultant and regulatory lead at MAIN5, to explore what it really takes to prepare for EMA’s PMS data enrichment deadlines.

Michiel’s top resources:

 * Take the first step to readiness. Download the IDMP Starter Pack  [https://en.ennov.com/insider/regulatory/idmp-starter-pack/]
 * Is your portfolio ready for enrichment? Access the downloadable PDF timeline [https://en.ennov.com/blog/regulatory-blog/portfolio-ready-data-enrichment/]
 * Understand long-term alignment strategy. Watch the PMS Data Alignment webinar [https://en.ennov.com/insider/regulatory/pms-data-alignment/]

Bonus: 

 * Want PMS-ready data without overhauling your RIM? Learn about Ennov EASI [https://en.ennov.com/solutions/regulatory/idmp-easi/]
   

PMS: Mind the (Data) Gap

Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in Life Sciences and Regulatory Affairs. This time, I’m joined by Plamena Entcheva-Dimitrov, PhD, RAC, founder of  Preferred Regulatory Consulting.

Combination Products Demystified

Combination products are more than the sum of their parts. From pre-filled syringes to gene therapies delivered via light-activated devices, these innovations span multiple product types as well as complexity levels. These variations and complexities can make a product's Regulatory journey challenging. Plamena walks us through the practical realities of navigating these challenges, with a few tips on how to make the journey a little less bumpy.

Our top resources:

 * Understand combination product requirements. Read the global strategy essentials blog [https://en.ennov.com/blog/regulatory-blog/combination-products-global-regulatory-strategy-essentials/]
 * Align regulatory and quality from day one. Watch the Med Device RIM & QMS session [https://en.ennov.com/insider/regulatory/compliance-without-compromise-med-device-rim-qms/]
 * Pharma-first RIM systems don’t work for devices. Learn about what you need instead [https://en.ennov.com/blog/regulatory-blog/medical-devices-arent-drugs-rim/]

Combo Products, Complex Rules: Regulatory Strategies for Combination Products

Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Paul Palmer, pharmaceutical consultant and Director at Pharma Quality Services, and David Kalb, Associate Technical Solution Director here at Ennov.

Together, we explore two timely questions: how can Regulatory and Quality work better together, and what 2025 regulatory updates should you be paying attention to?

Our top resources:

> Replace silos with a unified ecosystem: Read the case study [https://en.ennov.com/insider/quality/case-study-vetoquinol/]

> Plan your next system upgrade: See 2025 RIM & QMS best practices [https://en.ennov.com/blog/quality-blog/best-practices-implementing-rim-qms/]

> Why unified beats “integrated”: Read the platform comparison blog [https://en.ennov.com/blog/ditch-point-solutions-for-unified-platform/]

> Looking to streamline operations? Download the Unified RIM & QMS white paper [https://en.ennov.com/insider/regulatory/white-paper-unified-quality-rim/]

Beyond Silos: Unifying Quality & Regulatory

Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Pierre Stanislawski, our IDMP expert, and Josh Keliher, who’s leading the charge on AI at Ennov. Together, we dive into two major questions: what does AI really mean for regulatory affairs? And is IDMP finally ready for launch?

Our Top Resources:

> What to look for in an AI vendor. Download the AI Vendor Checklist [https://en.ennov.com/insider/guide-ai-vendor-checklist/]

> See what AI can actually do. Explore use cases in Life Sciences [https://en.ennov.com/platform/artificial-intelligence/#use-cases]

> Simplify agency correspondence. Watch the webinar to see AI in action [https://en.ennov.com/insider/managing-agency-correspondence-with-ai/]

> Know what’s coming next. View our updated EMA Timeline [https://en.ennov.com/blog/regulatory-blog/portfolio-ready-data-enrichment/]

> Current RIM not IDMP-ready? See how Ennov EASI can help [https://en.ennov.com/solutions/regulatory/idmp-easi/]

> Preparing for IDMP enrichment? Download the IDMP Starter Pack [https://en.ennov.com/insider/regulatory/idmp-starter-pack/]

AI Reality Check & The IDMP Countdown

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, I’m joined by Diarmuid Waide, regulatory expert, and Sean Carpenter, Product Manager.  We discuss the latest eCTD 4.0 news and a recent MHRA consultation on Medical Devices.

 * Know what’s coming, when. Check out our eCTD 4.0 implementation timeline [https://en.ennov.com/blog/regulatory-blog/ectd-4-0-timeline/]
 * Be part of the future of publishing. Download Diarmuid’s pilot readiness checklist [https://en.ennov.com/insider/regulatory/ectd-4-0-pilot-readiness-checklist/]
 * Get prepared. Catch up on the MHRA’s proposals [https://en.ennov.com/blog/mhra-medical-devices-in-vitro-diagnostics/]
 * Is your RIM system built for Medical Devices? Navigate MDR/IVDR and UDI with ease with Ennov RIM [https://en.ennov.com/insider/regulatory/compliance-without-compromise-med-device/]

eCTD 4.0 & Medical Devices: What's Happening in 2025?

Ennov (@ennovmarketing) · Zencastr

Ennov (@ennovmarketing)

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.